Clearance Summary
SOFT SILICONE ELASTOMER SPONGE EXPLANT received FDA 510(k) clearance under submission number K780987, sponsored by Medical Instrument Research Assoc., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1978-09-28.
- Submission: K780987
- Applicant / Sponsor: Medical Instrument Research Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4790
- Decision date: 1978-09-28
Classification & Regulation
This clearance is catalogued under FDA product code HOZ and 21 CFR 886.4790, within the Ophthalmic review panel as a Class II device.